Kornimate/medical-research-clean huggingface dataset:
selenium supplementation versus placebo in patients with graves' hyperthyroidism

Conditions: Graves' Hyperthyroidism

Summary: the purpose of this study is to investigate if selenium supplementation to the standard treatment with anti-thyroid drugs in patients with graves' hyperthyroidism, will lead to a fewer people with anti-thyroid treatment failure and faster remission, in terms of better quality of life during the first year of treatment and more patients staying in remission.


Eligibility criteria:
inclusion criteria: * age 18 years or older. * active graves' hyperthyroidism (suppressed tsh (\< 0.1) and positive trab) measured within the last two months prior to the inclusion date. * written informed consent exclusion criteria: * major co-morbidity, making the participants unlikely to continuously receive trial intervention in the intervention period. * previous treatment with radioactive iodine. * current atd treatment having been received for more than two months. * treatment with immunomodulatory drugs, such as cyclosporine a, methotrexate, cyclophosphamide. * allergy towards the components in the selenium and placebo pills. * pregnant or breast-feeding women. * intake of selenium supplementation above 70 µg per day (70 µg corresponds to the amount in a multivitamin tablet). * unable to read and understand danish. * lack of informed consent

Keywords: graves' hyperthyroidism graves' disease selenium quality of life thypro autoimmunity
dexmedetomidine and propofol as sole sedative agent for patients undergoing arteriovenous fistula surgery

Conditions: Arteriovenous Fistula

Summary: the investigators designed a prospective randomized study to compare the conventionally used sedative drug propofol with a latest alternative dexmedetomidine (dex), in patients with end-stage renal disease undergoing arteriovenous fistula (avf) surgery.


Eligibility criteria:
inclusion criteria: * inclusion criteria were patients undergoing arteriovenous fistula (avf) surgery aged between 20-70 with end stage renal failure on dialysis treatment. exclusion criteria: * exclusion criteria were decompensated respiratory or heart failure, liver failure, obesity (body mass index\>30), severe obstructive sleep apnea, need for additional different drugs for sedation, chronic use of alcohol, opioids or other sedative drugs,mental disorders, cognitive disorders, language problems and history of allergy to any medications used in this study.

Keywords: (avf) surgery
dose escalation study of il-7 and bi-therapy in hcv patients resistant after 12 weeks of bi-therapy (eclipse 1)

Conditions: Hepatitis C

Summary: this study will evaluate the safety of a new experimental drug, il-7, in people with hcv infection resistant after 12 weeks of bi-therapy.

this is a phase i inter-patient dose-escalation study assessing weekly doses of interleukin-7 (cyt107) in adult patients infected by genotype 1 virus of hepatitis c and resistant to standard treatment with peg-interferon and ribavirin (biotherapy)after 12 weeks of this standard bi-therapy. the dose escalation is aimed at establishing the safety of a biologically active doses of cyt107 added to the combination therapy of pegylated interferon-alpha and ribavirin. at each dose level, study patients will receive a subcutaneous administration of cyt107 per week for a total of 4 administrations. groups of 3 to 6 patients will be entered at each dose level of cyt107. four dose levels are planned. eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. standard bi-therapy will continue 4 weeks after cyt107 treatment discontinuation. the duration of study is approximately 11 weeks including screening period. participants have 1 hospitalization overnight and 8 clinic visits. the four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg. during the study visits the following may be done: * medical history, physical examination, blood tests every visit. * electrocardiogram (ekg) * chest x-ray study * liver/spleen imaging * blood sample collections at frequent intervals * urine tests several times during the study.

Eligibility criteria:
main inclusion criteria: * genotype i infected patients * age \> 18 years * absence of early viral response to a first treatment with peg-interferon-alpha plus ribavirin given for at least 12 weeks. absence of early viral response (evr) will be defined as detectable hcv with a decrease hcv rna load \< 2 logs, measured by a quantitative pcr tests, as compared to baseline levels measured by a similar technique * ongoing treatment by peg-interferon-alpha plus ribavirin at study entry main exclusion criteria: * infection by hbv * infection by hiv-1 and /or hiv-2 * apart from hcv infection, presence of active infection requiring a specific treatment or a hospitalization * cirrhosis (metavir f4) assessed by biopsy or fibroscan® or by liver biopsy within the last 6 months prior cyt107 treatment initiation. if assessed by fibroscan® patients with a result \> 10 kpa will be excluded * other liver disease (notably from alcoholic, metabolic or immunological origin) * body mass index (bmi) \> 30kg/m2 * inability to give informed consent * administration of growth factors (g-csf, epo) within the 12 weeks of the combination therapy

Keywords: interleukin-7 immune-based therapies hepatitis c chronic hepatitis resistance to peg-interferon and ribavirin bi-therapy immune specific responses to hcv phase 1 viral disease liver disease
prevention of caries in head and neck cancer survivors who underwent radiotherapy

Conditions: Caries,Dental; Head and Neck Cancer; Radiotherapy; Complications

Summary: one of the long-term side effects of head and neck radiotherapy (rt) is radiation-induced tooth decay. hyposalivation, associated with radiation therapy, further increases caries susceptibility and caries progression, due to the lack of salivary protective effects and of tooth minerals useful for remineralization processes, especially calcium phosphate (cap). dental extractions that could be required in case of severe tooth decay expose the patient to the risk of osteoradionecrosis of the jaws (i.e. the necrosis of the bone tissue following a local trauma, including surgical trauma). this protocol aims at verifying the effectiveness of cap mousse in the prevention of carious lesions, added to topical fluoride. a randomized controlled clinical trial will be performed comparing cap + fluoride treatment versus no treatment in head and neck cancer patients, who received radiotherapy. the hypothesis is that cap, which is lacking in the mouth of these patients due to hyposalivation, can combine with fluoride to promote remineralization, reducing the risk of carious lesions.


Eligibility criteria:
inclusion criteria: * previous head and neck radiotherapy for oncological treatment exclusion criteria: * complete edentulism * pregnancy or breastfeeding
integrating behavioral therapy in the management of temporomandibular disorders: a comprehensive evaluation using dc/tmd axis ii criteria

Conditions: Temporomandibular Joint Disorders; Chronic Pain; Anxiety Disorders

Summary: this study evaluates the efficacy of behavioral therapy, including cognitive behavioral therapy (cbt), relaxation techniques, and biofeedback, in managing temporomandibular disorders (tmd). it aims to address both the physical and psychological aspects of tmd, focusing on pain reduction, improved jaw function, and alleviating psychological distress such as anxiety and depression. participants are randomized into two groups: an intervention group receiving behavioral therapy and a control group receiving standard care. outcomes will be assessed using validated tools to measure pain intensity, jaw function, and psychological well-being at baseline, post-treatment, and at a 6-month follow-up. this research seeks to establish the role of behavioral therapy as a key component in the comprehensive management of tmd.


Eligibility criteria:
inclusion criteria: * adults aged 18-65 years. * diagnosed with temporomandibular disorders (tmd) based on dc/tmd axis i and axis ii criteria. * presenting with symptoms such as jaw pain, limited jaw movement, or psychosocial distress (anxiety, depression). * willing and able to provide informed consent. * able to comply with the study protocol and attend all follow-up visits. exclusion criteria: * severe systemic diseases or other neurological conditions that could interfere with treatment or outcomes. * history of psychiatric disorders unrelated to tmd, such as schizophrenia or bipolar d disorder. * pregnant or lactating women. * use of medications or treatments within the past month that could influence study outcomes (e.g., corticosteroids, strong analgesics). * individuals with severe dental or maxillofacial conditions requiring immediate surgical intervention. * non-compliance with previous medical advice or treatment for tmd. participants unable to understand or follow the study procedures due to language barriers or cognitive impairments.

Keywords: temporomandibular disorders temporomandibular joint cognitive behavioral therapy
insulin glulisine administered pre-meal versus post-meal in adult subjects with type 2 diabetes mellitus receiving insulin glargine as basal insulin

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to compare the change in weight from baseline to study week 52 in the per-protocol population of pre-meal insulin glulisine (apidra) versus post-meal apidra, in patients receiving insulin glargine (lantus) as basal insulin.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus for at least six months * 18 to 70 years of age, inclusive * a1c ≥ 7.5% and ≤ 10% * at least 3 months of continuous insulin and/or insulin analogue therapy (on at least 2 injections per day) +/- metformin prior to study entry * negative glutamic acid decarboxylase (gad) autoantibodies * ability and willingness to perform self-monitoring of blood glucose (smbg) at least four times a day, and at least 7 times daily during the 7-point blood glucose (bg) profile measurement days * ability and willingness to adhere to, and be compliant with, the study protocol * must be able to read english or spanish at the sixth grade level in order to complete the patient-reported outcomes component of the study * signed informed consent exclusion criteria: * subjects treated with sulfonylureas, thiazolidinediones (tzds), or any other oral antidiabetic drugs (at study entry) except for insulin and/or insulin analogues with or without metformin * planned pregnancy; or pregnant or lactating females * for subjects treated with metformin: serum creatinine ≥ 1.5 mg/dl (133 µmol/l) for males or ≥ 1.4 mg/dl (124 µmol/l) for females * serum creatinine ≥ 3.0 mg/dl (266 µmol/l) * any clinically significant renal disease (other than proteinuria) or hepatic disease * serum alt or ast levels greater than 2.5 x the upper limit of normal * any current malignancy or any cancer within the past 5 years (except for adequately treated basal cell skin cancer or cervical carcinoma in situ) * diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study * diagnosis of impaired dexterity or vision rendering the subject unable to administer multiple daily injections (mdis) * cardiac status new york heart association (nyha) iii-iv * hypersensitivity to lantus or apidra or any of their components * any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that, in the opinion of the investigator or sponsor, may interfere with the completion of the study. * subject unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study * subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
opening wedge high tibial osteotomy

Conditions: Osteoarthrosis of Knee; Osteoarthritis, Knee

Summary: a prospective, randomised controlled trial where clinical and radiological outcome of high tibial opening wedge osteotomy with physiotherapy is compared to physiotherapy alone while treating symptomatic medial knee osteoarthrosis.

90 symptomatic patients with mild to moderate medial knee osteoarthrosis are randomized to two groups: group 1 (hto-group) receive an diagnostic arthroscopy with high tibial opening wedge osteotomy (tomofix-plate). postoperatively a supervised physiotherapeutic rehabilitation program is started. group 2 (ft-group) receive the same supervised physiotherapeutic rehabilitation program without the hto or arthroscopy. primary outcome measure is composite score of knee injury and osteoarthritis outcome score (koos5). secondary outcome measures are pain (vas), koos subscales, objective physical performance measurements, progression of osteoarthrosis (x-ray, mri), change of mechanical axis, complications, treatment costs, rate of reoperation, revision to total knee arthroplasty (tka), biological markers of arthrosis progression, 15d (quality of life assessment), qaly (quality-adjusted life-year), work productivity and activity impairment questionnaire, work productivity and activity impairment questionnaire, sum of governmental benefits received. outcomes will be measured at 24, 60 and 120 months after the intervention.

Eligibility criteria:
inclusion criteria: * pain: subjective pain in the knee most of the month for at least one month during past 12 months. * knee range of motion (rom) at least 5-120 degrees * x-ray: medial joint space altman \> 1. lateral joint space altman \< 2. * mechanical axis \> 3 degrees varus alignment. * medial proximal tibial angle (mpta) \< 90 degrees * age 25-55. * written consent, accepts both treatment arms. exclusion criteria: * pain is caused by something else than medial knee osteoarthrosis * deficient rom (flexion contracture \> 10 degrees, flexion \< 110 degrees) * significant ligament instability * post traumatic oa * clinically relevant neurological disease (e.g. alzheimer´s disease) * clinically relevant metabolical disease (e.g. diabetes) * alcohol/drug abuse * infectious/inflammatory joint disease * previous knee area osteotomy or lower limb arthroplasty * smoking (\> 0 cigarette per day) * obesity (bmi \> 33) * pregnancy or hope of pregnancy in the following two years

Keywords: high tibial osteotomy osteoarthrosis tomofix randomized controlled trial
nalfurafine hydrochloride for pruritus in patients with primary biliary cholangitis

Conditions: Primary Biliary Cirrhosis

Summary: nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in japan, and in may 2015 the use of nalfurafine hydrochloride was officially approved in japan for pruritus in patients with chronic liver diseases including pbc. in the current study, the investigators aimed to assess pruritus and overall qol before and after administration of nalfurafine hydrochloride in patients with pbc. furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

primary biliary cholangitis (pbc, formally known as primary biliary cirrhosis) is a chronic cholestatic liver disease. taking advantage of ursodeoxycholic acid (udca), the outcome of patients with pbc has been improved, comparable to those in general population. however, pruritus, which is often a persisting and annoying symptom, may decrease the quality of life (qol) of patients with pbc. although anti-histamines are administered for this the efficacy is limited, and no drugs which was clearly proved to be effective for suppressing pruritus have been developed worldwide. nalfurafine hydrochloride is a selective kappa-opioid receptor agonist developed in japan, and in january 2009 approved for pruritus in patients with renal failure and under hemodialysis. a phase 3 trial of nalfurafine hydrochloride for pruritus in patients with chronic liver diseases was completed, indicating the efficacy as well as safety was confirmed. therefore, in may 2015 the use of nalfurafine hydrochloride was officially approved in japan for pruritus in patients with chronic liver diseases including pbc. however, only 59 patients with pbc were included and therefore it is still unclear whether nalfurafine chloride is effective in all pbc patients or a part of them, whether the effect of this drug depends on coadministered drugs or other complications, or whether this drug may improve qol overall in patients with pbc. in the current study, the investigators aimed to assess pruritus and overall qol before and after administration of nalfurafine hydrochloride in patients with pbc, to answer the clinical questions described above. furthermore, the investigators took serum sample from the enrolled patients and examine the association of pruritus with possible biomarkers.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pbc * complain of moderate or severe pruritus * decided by physician to be administered nalfurafine hydrochloride exclusion criteria * severe liver damage (child-pugh grade c) * allergic to nalfurafine hydrochloride * with no or mild pruritus
patient morbidity after palatal free gingival grafts with or without prf membranes coverage

Conditions: Postoperative Pain; Postoperative Complications; Gingival Recession

Summary: this study evaluates postoperative morbidity of patients that undergo free gingival graft harvesting from palate with or without use of autogenous prf (platelet rich fibrin) membranes to cover the donor site.in the test group venous blood sampling was done in order to prepare prf membranes used to cover the donor site, whereas in control group hemostatic agents with oxidized and regenerated cellulosa were used.


Eligibility criteria:
inclusion criteria: * fmps (full mouth plaque score) and fmbs (full mouth bleeding score) \< 20%, * presence of two adjacent miller's class i and ii recession defects on natural teeth (≥ 2mm in depth); exclusion criteria: * contraindications for periodontal surgery * taking medications or having diseases known to interfere with periodontal tissue health or healing and coagulation. * smoking more than 10 cigarettes a day * gingival recessions on molar teeth were excluded.

Keywords: connective tissue graft platelet concentrates prf mucogingival surgery
hypofractionated intensity modulated and image guided radiotherapy for localized prostate cancer

Conditions: Prostatic Neoplasms

Summary: hypofractionated intensity modulated and image guided radiotherapy (hypoigrt) with fewer high-fraction-size treatments would be beneficial for prostate cancer because it would deliver a larger biological-equivalent dose to the tumor than would conventional treatment in 1.8-2.0 gy fractions, while maintaining a similar or lower incidence of late normal tissue reactions. thus, the investigators aim to assess the hypothesis that hypoigrt treatment for localized prostate cancer will improve the therapeutic ratio by either: 1. reducing normal tissue, mainly genitourinary and gastrointestinal, toxicity and / or 2. improving tumour control, mainly freedom from biochemical failure survival.

the investigator chose to study a hypoigrt regimen, in participants with prostate adenocarcinoma, tumor which is considered to present a low α / β, and therefore benefit from this approach. primary outcome measures: 1. acute and late radiation induced toxicities. secondary outcome measures: 1. freedom from prostate cancer recurrence - freedom from biochemical failure survival; 2. cause specific and overall survival 3. aspects of quality of life and health economics study design: allocation: prospective allocation endpoint classification: feasibility study (toxicity assessment) intervention model: single assignment masking: open label primary purpose: treatment eligibility ages eligible for study: 18 years and older genders eligible for study: both accepts healthy volunteers: no study population: men with localized histologically confirmed t1b-t4 n0 and m0 prostate cancer.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed, previously untreated locally confined adenocarcinoma of the prostate 2. patients older than 18 years old 3. patients who accept to perform follow up in the radiation oncology department 4. performance status ≥ 70 5. written informed consent exclusion criteria: 1. prior pelvic radiotherapy, radical prostatectomy, brachytherapy, cryotherapy or other local treatment 2. presenting with positive pelvic lymph nodes or metastatic at the diagnosis (m1)
a study of doxorubicin in the treatment of aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: to study the natural course of aids related kaposi's sarcoma and to determine the usefulness and safety of weekly administration of small doses of doxorubicin. doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. when small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced.

doxorubicin is one of the most active of all antitumor agents but at currently used doses toxicity is common. when small doses are administered on a weekly schedule, the toxicity of the drug appears to be reduced. patients are stratified for non-therapy purposes into 2 groups; doxorubicin is given intravenously (iv) every week on an outpatient basis. patients are monitored carefully, and weekly blood samples are taken to determine the effectiveness and safety of treatment. patients are evaluated for toxicity after one dose of the drug and weekly thereafter. patients are evaluated for response to the drug after 4 weeks and monthly thereafter.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * ongoing and/or maintenance therapy for opportunistic infection. * medications for nausea, vomiting, and diarrhea resulting from drug. patients must have aids related kaposi's sarcoma. * patients may demonstrate positive blood cultures for mycobacterium avium-complex or cytomegalovirus. exclusion criteria co-existing condition: patients with the following conditions will be excluded: * patients with active opportunistic infection. * patients with concurrent neoplasm other than squamous cell carcinoma of the skin or in situ carcinoma of the cervix. * patients with significant neurologic, cardiac, or liver disease. concurrent medication: excluded: * antiretroviral agents. * immunomodulators. * corticosteroids. * experimental drugs. the following patients will be excluded from the study: * patients with lymphadenopathy alone and/or visceral disease alone secondary to kaposi's sarcoma. prior medication: excluded: * cytotoxic chemotherapy. * excluded within 30 days of study entry: * antiretroviral agents. * biologic modifiers. * corticosteroids. prior treatment: excluded: * total body electron beam therapy. * excluded within 30 days of study entry: * radiation therapy.

Keywords: doxorubicin drug evaluation acquired immunodeficiency syndrome